Study Stopped
The study was withdrawn for administrative reasons
Inhaled Corticosteroids on Airway Smooth Muscle in Asthma
The Effect of Inhaled Corticosteroids (ICS) on Airway Smooth Muscle in Asthma
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
The main objective is to evaluate how treatment with inhaled corticosteroids (ICS) affects the characteristics of airway smooth muscle (ASM) cells from asthmatic subjects. Our hypothesis is that airway smooth muscle cell dysfunction plays an important role in the pathogenesis of asthma, and that treatment with inhaled corticosteroids reverses the abnormalities in airway smooth muscle cell function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2008
Typical duration for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedSeptember 13, 2019
September 1, 2019
2.7 years
April 16, 2008
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in ASM mass, proliferation and migration after ICS therapy; changes in chemokine release after ICS therapy
4 weeks
Secondary Outcomes (1)
Changes in sub-basement membrane thickness and inflammatory cell count after ICS therapy
4 weeks
Study Arms (1)
overall
EXPERIMENTALInterventions
inhaled budesonide (turbohaler) 400 micrograms twice a day for 4 weeks
Eligibility Criteria
You may qualify if:
- Physician diagnosis of asthma
- Age 18-60
- Intermittent asthma symptoms \< once/week
- FEV1\>80% of predicted
- Not on inhaled corticosteroid therapy
You may not qualify if:
- Previous long-term use of inhaled corticosteroids (within 1 year of entry into study)
- Past history of hypersensitivity to budesonide
- Current smokers, or less than 3 years since quitting smoking
- Less than 4 weeks from an exacerbation
- On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
- Concomitant anti-IgE therapy
- Pregnancy
- Previous bronchoscopy within three months of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asthma lab, Royal Brompton Hospital, Sydney Street
London, SW3 6NP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kian F Chung, MBBS FRCP MD DSc
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 21, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
September 13, 2019
Record last verified: 2019-09